Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations (ISO 29001:2020)

This document defines quality management system requirements for product and service supply
organizations to the petroleum, petrochemical and natural gas industries.
This document is written as a supplement to ISO 9001:2015. The supplementary requirements and
guidance to ISO 9001:2015 have been developed to manage supply chain risks and opportunities
associated with the petroleum, petrochemical and natural gas industries and to provide a framework
for aligning requirements with complementary standards employed within the industries.

Erdöl-, petrochemische und Erdgasindustrie - Sektorspezifische Qualitätsmangementsysteme - Anforderungen an Hersteller- und Serviceorganisationen (ISO 29001:2020)

Industries du pétrole, de la pétrochimie et du gaz naturel - Systèmes de management de la qualité spécifiques au secteur - Exigences pour les organismes de fourniture de produits et de services (ISO 29001:2020)

Petrokemična industrija ter industrija za predelavo nafte in zemeljskega plina - Sektorsko specifični sistemi vodenja kakovosti - Zahteve za proizvodne in storitvene organizacije (ISO 29001:2020)

General Information

Status
Published
Public Enquiry End Date
30-Apr-2018
Publication Date
08-Jun-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Jun-2020
Due Date
09-Aug-2020
Completion Date
09-Jun-2020

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SLOVENSKI STANDARD
SIST EN ISO 29001:2020
01-september-2020
Nadomešča:
SIST-TS CEN ISO/TS 29001:2012
Petrokemična industrija ter industrija za predelavo nafte in zemeljskega plina -
Sektorsko specifični sistemi vodenja kakovosti - Zahteve za proizvodne in
storitvene organizacije (ISO 29001:2020)
Petroleum, petrochemical and natural gas industries - Sector-specific quality
management systems - Requirements for product and service supply organizations (ISO
29001:2020)
Erdöl-, petrochemische und Erdgasindustrie - Sektorspezifische
Qualitätsmangementsysteme - Anforderungen an Hersteller- und Serviceorganisationen
(ISO 29001:2020)
Industries du pétrole, de la pétrochimie et du gaz naturel - Systèmes de management de
la qualité spécifiques au secteur - Exigences pour les organismes de fourniture de
produits et de services (ISO 29001:2020)
Ta slovenski standard je istoveten z: EN ISO 29001:2020
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
75.020 Pridobivanje in predelava Extraction and processing of
nafte in zemeljskega plina petroleum and natural gas
SIST EN ISO 29001:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 29001:2020

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SIST EN ISO 29001:2020


EN ISO 29001
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2020
EUROPÄISCHE NORM
ICS 03.100.70; 75.020 Supersedes CEN ISO/TS 29001:2011
English Version

Petroleum, petrochemical and natural gas industries -
Sector-specific quality management systems -
Requirements for product and service supply
organizations (ISO 29001:2020)
Industries du pétrole, de la pétrochimie et du gaz Erdöl-, petrochemische und Erdgasindustrie -
naturel - Systèmes de management de la qualité Sektorspezifische Qualitätsmangementsysteme -
spécifiques au secteur - Exigences pour les organismes Anforderungen an Hersteller- und
de fourniture de produits et de services (ISO Serviceorganisationen (ISO 29001:2020)
29001:2020)
This European Standard was approved by CEN on 26 April 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 29001:2020 E
worldwide for CEN national Members.

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SIST EN ISO 29001:2020
EN ISO 29001:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 29001:2020
EN ISO 29001:2020 (E)
European foreword
This document (EN ISO 29001:2020) has been prepared by Technical Committee ISO/TC 67 "Materials,
equipment and offshore structures for petroleum, petrochemical and natural gas industries" in
collaboration with Technical Committee CEN/TC 12 “Materials, equipment and offshore structures for
petroleum, petrochemical and natural gas industries” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 29001:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 29001:2020 has been approved by CEN as EN ISO 29001:2020 without any modification.


3

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SIST EN ISO 29001:2020

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SIST EN ISO 29001:2020
INTERNATIONAL ISO
STANDARD 29001
First edition
2020-05
Petroleum, petrochemical and natural
gas industries — Sector-specific
quality management systems —
Requirements for product and service
supply organizations
Industries du pétrole, de la pétrochimie et du gaz naturel — Systèmes
de management de la qualité spécifiques au secteur — Exigences pour
les organismes de fourniture de produits et de services
Reference number
ISO 29001:2020(E)
©
ISO 2020

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Context of the organization . 3
4.1 Understanding the organization and its context . 3
4.2 Understanding the needs and expectations of interested parties . 4
4.3 Determining the scope of the quality management system . 4
4.4 Quality management system and its processes . 5
5 Leadership . 6
5.1 Leadership and commitment . 6
5.1.1 General. 6
5.1.2 Customer focus . 7
5.2 Policy . 7
5.2.1 Establishing the quality policy . 7
5.2.2 Communicating the quality policy . 7
5.3 Organizational roles, responsibilities and authorities. 8
6 Planning . 8
6.1 Actions to address risks and opportunities . 8
6.2 Quality objectives and planning to achieve them .10
6.3 Planning of changes .10
7 Support .11
7.1 Resources .11
7.1.1 General.11
7.1.2 People .11
7.1.3 Infrastructure .11
7.1.4 Environment for the operation of processes .12
7.1.5 Monitoring and measuring resources .13
7.1.6 Organizational knowledge .14
7.2 Competence .14
7.3 Awareness .15
7.4 Communication .15
7.5 Documented information .16
7.5.1 General.16
7.5.2 Creating and updating .16
7.5.3 Control of documented information .17
8 Operation .18
8.1 Operational planning and control .18
8.2 Requirements for products and services .19
8.2.1 Customer communication .19
8.2.2 Determining the requirements for products and services .19
8.2.3 Review of the requirements for products and services .20
8.2.4 Changes to requirements for products and services .20
8.3 Design and development of products and services .21
8.3.1 General.21
8.3.2 Design and development planning .21
8.3.3 Design and development inputs .22
8.3.4 Design and development controls .22
8.3.5 Design and development outputs .23
8.3.6 Design and development changes . .23
© ISO 2020 – All rights reserved iii

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

8.4 Control of externally provided processes, products and services .24
8.4.1 General.24
8.4.2 Type and extent of control .24
8.4.3 Information for external providers .25
8.5 Production and service provision .26
8.5.1 Control of production and service provision .26
8.5.2 Identification and traceability .27
8.5.3 Property belonging to customers or external providers .27
8.5.4 Preservation .27
8.5.5 Post-delivery activities .28
8.5.6 Control of changes .28
8.6 Release of products and services .29
8.7 Control of nonconforming outputs .29
9 Performance evaluation .30
9.1 Monitoring, measurement, analysis and evaluation .30
9.1.1 General.30
9.1.2 Customer satisfaction .30
9.1.3 Analysis and evaluation .31
9.2 Internal audit .32
9.3 Management review .32
9.3.1 General.32
9.3.2 Management review inputs .33
9.3.3 Management review outputs .33
10 Improvement .34
10.1 General .34
10.2 Nonconformity and corrective action .34
10.3 Continual improvement .35
Annex A (informative) Clarification of new structure, terminology and concepts .36
Annex B (informative) Other International Standards on quality management and quality
management systems developed by ISO/TC 176 .41
Annex C (informative) Risk and opportunity management and conformity assessment
processes .45
Bibliography .51
iv © ISO 2020 – All rights reserved

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore
structures for petroleum, petrochemical and natural gas industries, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 12, Materials, equipment and
offshore structures for petroleum, petrochemical and natural gas industries, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This first edition cancels and replaces ISO/TS 29001:2010, which has been technically revised. The
main changes compared to the previous edition are as follows:
— alignment with ISO 9001:2015.
The boxed text is reproduced from ISO 9001:2015 unaltered and in its entirety. The petroleum,
petrochemical and natural gas industry sector-specific supplemental requirements and guidance are
provided outside the boxed text.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

Introduction
0.1  General
ISO 9001:2015, Quality management systems — Requirements
0.1  General
The adoption of a quality management system is a strategic decision for an organization that can
help to improve its overall performance and provide a sound basis for sustainable development
initiatives.
The potential benefits to an organization of implementing a quality management system based on
this International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-
Act (PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes
and its quality management system to deviate from the planned results, to put in place preventive
controls to minimize negative effects and to make maximum use of opportunities as they arise (see
Clause A.4).
vi © ISO 2020 – All rights reserved

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SIST EN ISO 29001:2020
ISO 29001:2020(E)


Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
0.2  Quality management principles
ISO 9001:2015, Quality management systems — Requirements
0.2  Quality management principles
This International Standard is based on the quality management principles described in ISO 9000.
The descriptions include a statement of each principle, a rationale of why the principle is important
for the organization, some examples of benefits associated with the principle and examples of typical
actions to improve the organization's performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
© ISO 2020 – All rights reserved vii

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SIST EN ISO 29001:2020
ISO 29001:2020(E)

0.3  Process approach
0.3.1  General
ISO 9001:2015, Quality management systems — Requirements
0.3.1  General
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization's
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that
the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and ma
...

SLOVENSKI STANDARD
oSIST prEN ISO 29001:2018
01-april-2018
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6HNWRUVNRVSHFLILþQLVLVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DSURL]YRGQHLQ
VWRULWYHQHRUJDQL]DFLMH ,62',6
Petroleum, petrochemical and natural gas industries - Sector-specific quality
management systems - Requirements for product and service supply organizations
(ISO/DIS 29001:2018)
Erdöl-, petrochemische und Erdgasindustrie - Sektorspezifische
Qualitätsmangementsysteme - Anforderungen an Hersteller- und Serviceorganisationen
(ISO/DIS 29001:2018)
Industries du pétrole, de la pétrochimie et du gaz naturel - Systèmes de management de
la qualité spécifiques au secteur - Exigences pour les organismes de fourniture de
produits et de services (ISO/DIS 29001:2018)
Ta slovenski standard je istoveten z: prEN ISO 29001
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
75.020 Pridobivanje in predelava Extraction and processing of
nafte in zemeljskega plina petroleum and natural gas
oSIST prEN ISO 29001:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 29001:2018

---------------------- Page: 2 ----------------------
oSIST prEN ISO 29001:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 29001
ISO/TC 67 Secretariat: NEN
Voting begins on: Voting terminates on:
2018-02-21 2018-05-16
Petroleum, petrochemical and natural gas industries —
Sector-specific quality management systems —
Requirements for product and service supply
organizations
Industries du pétrole, de la pétrochimie et du gaz naturel — Systèmes de management de la qualité
spécifiques au secteur — Exigences pour les organismes de fourniture de produits et de services
ICS: 03.100.70; 75.020
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 29001:2018(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2018

---------------------- Page: 3 ----------------------
oSIST prEN ISO 29001:2018
ISO/DIS 29001:2018(E) ISO/DIS 29001:2017(E)

8 Operation . 25
8.1 Operational planning and control . 25
8.2 Requirements for products and services . 26
8.2.1 Customer communication . 26
8.2.2 Determining the requirements for products and services . 26
8.2.3 Review of the requirements for products and services . 26
8.2.4 Changes to requirements for products and services . 27
8.3 Design and development of products and services . 27
8.3.1 General . 27
8.3.2 Design and development planning . 27
8.3.3 Design and development inputs . 28
8.3.4 Design and development controls . 28
8.3.5 Design and development outputs . 29
8.3.6 Design and development changes . 29
8.4 Control of externally provided processes, products and services . 29
8.4.1 General . 29
8.4.2 Type and extent of control . 30
8.4.3 Information for external providers . 30
8.5 Production and service provision . 31
8.5.1 Control of production and service provision . 31
8.5.2 Identification and traceability . 32
8.5.3 Property belonging to customers or external providers . 32
8.5.4 Preservation . 32
8.5.5 Post-delivery activities . 33
8.5.6 Control of changes . 33
8.6 Release of products and services . 33
8.7 Control of nonconforming outputs . 34
9 Performance evaluation . 34
9.1 Monitoring, measurement, analysis and evaluation . 34
9.1.1 General . 34
9.1.2 Customer satisfaction. 35
9.1.3 Analysis and evaluation . 35
9.2 Internal audit . 36
9.3 Management review . 36
9.3.1 General . 36
9.3.2 Management review inputs. 36
9.3.3 Management review outputs . 37
10 Improvement. 37
10.1 General . 37
10.2 Nonconformity and corrective action . 38
10.3 Continual improvement . 38
Annex A (informative) Clarification of new structure, terminology and concepts . 39
COPYRIGHT PROTECTED DOCUMENT
A.1 Structure and terminology . 39
A.2 Products and services . 40
© ISO 2018
A.3 Understanding the needs and expectations of interested parties . 40
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
A.4 Risk-based thinking . 40
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
A.5 Applicability . 41
below or ISO’s member body in the country of the requester.
A.6 Documented information . 41
ISO copyright office
A.7 Organizational knowledge . 42
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
A.8 Control of externally provided processes, products and services . 42
Tel. +41 22 749 01 11
Annex B (informative) Other International Standards on quality management and
Fax +41 22 749 09 47
copyright@iso.org
quality management systems developed by ISO/TC 176 . 43
www.iso.org
Published in Switzerland
© ISO 2017 – All rights reserved 3
ii © ISO 2018 – All rights reserved

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oSIST prEN ISO 29001:2018
ISO/DIS 29001:2018(E)

Contents
Foreword . 5
Introduction . 6
0.0 Field of application . 6
0.1 General . 6
0.2 Quality management principles . 7
0.3 Process approach. 7
0.3.1 General . 7
0.3.2 Plan-Do-Check-Act cycle . 8
0.3.3 Risk-based thinking . 9
0.4 Relationship with other management system standards . 10
1 Scope . 11
2 Normative references . 11
3 Terms and definitions . 11
4 Context of the organization . 14
4.1 Understanding the organization and its context . 14
4.2 Understanding the needs and expectations of interested parties . 14
4.3 Determining the scope of the quality management system . 14
4.4 Quality management system and its processes . 15
5 Leadership. 16
5.1 Leadership and commitment . 16
5.1.1 General . 16
5.1.2 Customer focus . 16
5.2 Policy . 17

5.2.1 Establishing the quality policy . 17
5.2.2 Communicating the quality policy . 17
5.3 Organizational roles, responsibilities and authorities . 17
6 Planning . 18
6.1 Actions to address risks and opportunities . 18
6.2 Quality objectives and planning to achieve them . 19
6.3 Planning of changes . 19
7 Support . 20
7.1 Resources . 20
7.1.1 General . 20
7.1.2 People . 20
7.1.3 Infrastructure . 20
7.1.4 Environment for the operation of processes . 21
7.1.5 Monitoring and measuring resources . 21
7.1.6 Organizational knowledge . 22
7.2 Competence . 22
7.3 Awareness . 23
7.4 Communication . 23
7.5 Documented information . 24
7.5.1 General . 24
7.5.2 Creating and updating. 24
7.5.3 Control of documented information . 24
© ISO 2018 – All rights reserved 2

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oSIST prEN ISO 29001:2018
ISO/DIS 29001:2018(E)
8 Operation . 25
8.1 Operational planning and control . 25
8.2 Requirements for products and services . 26
8.2.1 Customer communication . 26
8.2.2 Determining the requirements for products and services . 26
8.2.3 Review of the requirements for products and services . 26
8.2.4 Changes to requirements for products and services . 27
8.3 Design and development of products and services . 27
8.3.1 General . 27
8.3.2 Design and development planning . 27
8.3.3 Design and development inputs . 28
8.3.4 Design and development controls . 28
8.3.5 Design and development outputs . 29
8.3.6 Design and development changes . 29
8.4 Control of externally provided processes, products and services . 29
8.4.1 General . 29
8.4.2 Type and extent of control . 30
8.4.3 Information for external providers . 30
8.5 Production and service provision . 31
8.5.1 Control of production and service provision . 31
8.5.2 Identification and traceability . 32
8.5.3 Property belonging to customers or external providers . 32
8.5.4 Preservation . 32
8.5.5 Post-delivery activities . 33
8.5.6 Control of changes . 33
8.6 Release of products and services . 33
8.7 Control of nonconforming outputs . 34
9 Performance evaluation . 34
9.1 Monitoring, measurement, analysis and evaluation . 34
9.1.1 General . 34
9.1.2 Customer satisfaction. 35
9.1.3 Analysis and evaluation . 35
9.2 Internal audit . 36
9.3 Management review . 36
9.3.1 General . 36
9.3.2 Management review inputs. 36
9.3.3 Management review outputs . 37
10 Improvement. 37
10.1 General . 37
10.2 Nonconformity and corrective action . 38
10.3 Continual improvement . 38
Annex A (informative) Clarification of new structure, terminology and concepts . 39
A.1 Structure and terminology . 39
A.2 Products and services . 40
A.3 Understanding the needs and expectations of interested parties . 40
A.4 Risk-based thinking . 40
A.5 Applicability . 41
A.6 Documented information . 41
A.7 Organizational knowledge . 42
A.8 Control of externally provided processes, products and services . 42
Annex B (informative) Other International Standards on quality management and
quality management systems developed by ISO/TC 176 . 43
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oSIST prEN ISO 29001:2018
ISO/DIS 29001:2018(E)
Annex C (informative) Risk management and conformity assessment processes . 47
C.1 General . 47
C.2 Risk classification principles . 47
C.3 Risk management and conformity assessment process . 48
C.3.1 Customer's scope and context . 48
C.3.2 Undertaking risk assessment . 48
C.3.3 Determination of control and verification requirements . 49
C.4 Control of externally provided processes, products and services . 49
C.4.1 Scope of externally provided activity . 49
C.4.2 Potential provider capability assessment . 50
C.4.3 Conformity assessment requirements for external providers . 50
C.4.4 Control of external providers during execution of scope . 50
Appendix 1 – Examples of conformity assessment activities . 51
Bibliography . 53


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oSIST prEN ISO 29001:2018
ISO/DIS 29001:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a
subject for which a technical committee has been established has the right to be represented on
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with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance
are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria
needed for the different types of ISO documents should be noted. This document was drafted in
accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. ISO shall not be h
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